GRAS Application

"GRAS" is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

• Under sections 201(s) and 409 of the Act, and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive. General recognition of safety through scientific procedures is based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
• Under 21 CFR 170.30(c) and 170.3(f), general recognition of safety through experience based on common use in foods requires a substantial history of consumption for food use by a significant number of consumers.

How can EZ FDA Consulting help you with your GRAS status?

EZFDA consulting understands the complexities of GRAS regulations, and our team of experts can help your company understand the science and regulatory requirements to support your ingredient's GRAS status.

To determine the GRAS status of a food ingredient use, both technical evidence of safety and a basis for drawing conclusions from such evidence are required. This evidence must be assessed by independent scientists who have relevant experience and scientific training qualified to assess the safety of food ingredients.

While GRAS notification to FDA is voluntary, a positive FDA response provides assurance of safety to the end user of the ingredient and facilitates the import of ingredients produced outside of the United States.

The complex and often extensive requirements supporting GRAS status for ingredients require expert advice to develop an effective regulatory strategy. EZFDA consulting employs talented regulatory and scientific experts with decades of experience preparing GRAS documents and serving as liaisons with expert panels and FDA to ensure successful and timely marketing of ingredients.

GRAS services of EZFDA consulting include:

• Conducting feasibility assessments and assisting with the development of a successful regulatory strategy 
• Conducting literature searches and data gathering 
• Identifying technical and scientific data gaps and recommending solutions 
• Coordinating the conduct of toxicological studies when required 
• Facilitating the publication of pivotal data to meet the "general recognition" requirement of GRAS 
• Providing dietary exposure estimates and safety assessments 
• GRAS dossier preparation for expert panel review 
• Coordinating and facilitating expert panel review 
• Preparing GRAS notification submissions to FDA
• Following up communication with FDA: calls, emails and reviews 

How can we help you save time and money to entry US market

Our skilled team can help you navigate through the complex GRAS Notification process by assisting with the entire paperwork submission. We will:

• Determine whether GRAS status is required for your ingredient
• Help with a successful regulatory strategy
• Detect scientific and technical data gaps and suggest solutions
• Conduct research for scientific evidence to ensure substance is safe 
• Prepare and submit GRAS notifications and liaison with the FDA
• Mediate expert panel reports on GRAS conclusions
• Self-affirmed GRAS compliance
• Choosing between ODI, NDI, GRAS food certification